Systems and methods to provide two-way communications

ABSTRACT

An electronic and transducer device can be attached, adhered, or otherwise embedded into or upon a removable oral appliance or other oral device to form a two-way communication assembly. In another embodiment, the device provides an electronic and transducer device that can be attached, adhered, or otherwise embedded into or upon a removable oral appliance or other oral device to form a medical tag containing patient identifiable information. Such an oral appliance may be a custom-made device fabricated from a thermal forming process utilizing a replicate model of a dental structure obtained by conventional dental impression methods. The electronic and transducer assembly may receive incoming sounds either directly or through a receiver to process and amplify the signals and transmit the processed sounds via a vibrating transducer element coupled to a tooth or other bone structure, such as the maxillary, mandibular, or palatine bone structure.

BACKGROUND

Traditionally field workers such as fire fighters and plant workerscommunicate using two way radios such as radios supplied by Motorola,Inc. As mentioned in United States Patent 20070142072, two way radiosallow users the ability to wirelessly communicate with others on a smallnetwork. Most two way radios use various channels or frequencies forcommunication. Monitoring of more than one channel allows a user tocommunicate with a plurality of people for a variety of purposes. In asecurity environment, for instance, channel 1 may be used to communicateabout and monitor emergency conditions. Channel 2 may be used tocommunicate about and monitor major security threats. Channel 3 may beused to communicate about and monitor minor security threats. A user maymonitor all three channels by using a two way radio having a scanningmode. However, the user is limited to transmitting on the most recentlyscanned channel. If the user fails to transmit within a shortpredetermined period of time, the two way radio may scan to a newchannel. The user then needs to manually select the channel, wastingvaluable time and eliminating the ability to scan other channels duringthe selection process.

Other devices that can be used instead of two way radios includecellular telephones. These devices have revolutionized personalcommunication by allowing telephone access from anywhere within reach ofwireless network infrastructure (e.g., cellular networks, communicationsatellites, or other infrastructure of other wireless networks adaptedfor voice communications). In as much as the use of handheld wirelessvoice communication devices is not restricted to homes and offices, suchdevices will often be used in environments where there is considerableambient noise. Examples of such environments include busy urbansettings, inside moving vehicles and on factory floors. Ambient noise inan environment can degrade the intelligibility of received voice audioand thereby interfere with users' ability to communicate.

United States Patent 20060270467 discusses enhancing the intelligibilityof speech emitted into a noisy environment by filtering ambient noisewith a filter that simulates the physical blocking of noise by at leasta part of a voice communication device and determining a frequencydependent SNR of received voice audio relative to ambient noise iscomputed on a perceptual (e.g. Bark) frequency scale. Formants areidentified and the SNR in bands including certain formants are modifiedwith formant enhancement gain factors in order to improveintelligibility. However, in certain industrial, emergency, governmentand military applications, such noise filtering is insufficient toprovide high quality, hands-free, yet inconspicuous communicationcapability for field personnel.

SUMMARY

Methods and apparatus that support communications and/or medicalinformation monitoring for field personnel are disclosed. In oneembodiment, a device provides an electronic and transducer device thatcan be attached, adhered, or otherwise embedded into or upon a removableoral appliance or other oral device to form a two-way communicationassembly.

In another embodiment, the device provides an electronic and transducerdevice that can be attached, adhered, or otherwise embedded into or upona removable oral appliance or other oral device to form a medical tagcontaining patient identifiable information. Such an oral appliance maybe a custom-made device fabricated from a thermal forming processutilizing a replicate model of a dental structure obtained byconventional dental impression and/or imaging methods. The electronicand transducer assembly may receive incoming sounds either directly orthrough a receiver to process and amplify the signals and transmit theprocessed sounds via a vibrating transducer element coupled to a toothor other bone structure, such as the maxillary, mandibular, or palatinebone structure.

Advantages of preferred embodiments may include one or more of thefollowing. The system is a multi-purpose communication platform that isrugged, wireless and secure. The system provides quality, hands-free,yet inconspicuous communication capability for field personnel. Inembodiments that support voice and data from the field, the systemautomates the capture and transfer of data in the field to a centralremote computer for further processing. By minimizing human datacollection, the system reduces paperwork, allows for the collection ofmore complete field information, eliminates redundant data entry, andincreases responsiveness to fluid situations present in industrialenvironment or emergency, local government or military incidents.

For applications that require health monitoring, the system enableshealthcare providers to make certain all patient episodes are capturedand recorded no matter the environment. Most importantly; the systemprovides a standard of care to field personnel by providing access topreviously unavailable information. For military and emergencyapplications, the system provides commanders with real time visibilityof their readiness status and provides support for medical command andcontrol, telemedicine and medical informatics applications across thecontinuum of the spectrum of military medical operations but especiallyfor the first responder and far forward medical facilities. Withsoldiers deployed in many different parts of the world, the systemallows medical professionals to capture patient episodes anywhere,anytime, and ensure complete patient information is recorded andtransferred to the soldier's medical records at home. Additionally, thesystem provides a dental identification capability which is retained onthe individual and thus is less subject to destruction, loss,forgetfulness, or any of numerous other problems.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C shows exemplary two way communication devices.

FIG. 1D illustrates the dentition of a patient's teeth and one variationof a two-way communication device which is removably placed upon oragainst the patient's tooth or teeth as a removable oral appliance.

FIG. 2A illustrates a perspective view of the lower teeth showing oneexemplary location for placement of the removable oral appliance two-waycommunication device.

FIG. 2B illustrates another variation of the removable oral appliance inthe form of an appliance which is placed over an entire row of teeth inthe manner of a mouthguard.

FIG. 2C illustrates another variation of the removable oral appliancewhich is supported by an arch.

FIG. 2D illustrates another variation of an oral appliance configured asa mouthguard.

FIG. 3 illustrates a detail perspective view of the oral appliancepositioned upon the patient's teeth utilizable in combination with atransmitting assembly external to the mouth and wearable by the patientin another variation of the device.

FIG. 4 shows an illustrative configuration of the individual componentsin a variation of the oral appliance device having an externaltransmitting assembly with a receiving and transducer assembly withinthe mouth.

FIG. 5 shows an illustrative configuration of another variation of thedevice in which the entire assembly is contained by the oral appliancewithin the user's mouth.

FIG. 6A shows a partial cross-sectional view of an oral appliance placedupon a tooth with an electronics/transducer assembly adhered to thetooth surface via an adhesive.

FIG. 6B shows a partial cross-sectional view of a removable backingadhered onto an adhesive surface.

FIG. 7 shows a partial cross-sectional view of another variation of anoral appliance placed upon a tooth with an electronics/transducerassembly pressed against the tooth surface via an osmotic pouch.

FIG. 8 shows a partial cross-sectional view of another variation of anoral appliance placed upon a tooth with an electronics/transducerassembly pressed against the tooth surface via one or more biasingelements.

FIG. 9 illustrates another variation of an oral appliance having anelectronics assembly and a transducer assembly separated from oneanother within the electronics and transducer housing of the oralappliance.

FIGS. 10 and 11 illustrate additional variations of oral appliances inwhich the electronics and transducer assembly are maintainable againstthe tooth surface via a ramped surface and a biasing element.

FIG. 12 shows yet another variation of an oral appliance having aninterfacing member positioned between the electronics and/or transducerassembly and the tooth surface.

FIG. 13 shows yet another variation of an oral appliance having anactuatable mechanism for urging the electronics and/or transducerassembly against the tooth surface.

FIG. 14 shows yet another variation of an oral appliance having a cammechanism for urging the electronics and/or transducer assembly againstthe tooth surface.

FIG. 15 shows yet another variation of an oral appliance having aseparate transducer mechanism positionable upon the occlusal surface ofthe tooth for transmitting vibrations.

FIG. 16 illustrates another variation of an oral appliance having amechanism for urging the electronics and/or transducer assembly againstthe tooth surface utilizing a bite-actuated mechanism.

FIG. 17 shows yet another variation of an oral appliance having acomposite dental anchor for coupling the transducer to the tooth.

FIGS. 18A and 18B show side and top views, respectively, of an oralappliance variation having one or more transducers which may bepositioned over the occlusal surface of the tooth.

FIGS. 19A and 19B illustrate yet another variation of an oral appliancemade from a shape memory material in its pre-formed relaxedconfiguration and its deformed configuration when placed over or uponthe patient's tooth, respectively, to create an interference fit.

FIG. 20 illustrates yet another variation of an oral appliance made froma pre-formed material in which the transducer may be positioned betweenthe biased side of the oral appliance and the tooth surface.

FIG. 21 illustrates a variation in which the oral appliance may beomitted and the electronics and/or transducer assembly may be attachedto a composite dental anchor attached directly to the tooth surface.

FIGS. 22A and 22B show partial cross-sectional side and perspectiveviews, respectively, of another variation of an oral appliance assemblyhaving its occlusal surface removed or omitted for patient comfort.

FIGS. 23A and 23B illustrate perspective and side views, respectively,of an oral appliance which may be coupled to a screw or post implanteddirectly into the underlying bone, such as the maxillary or mandibularbone.

FIG. 24 illustrates another variation in which the oral appliance may becoupled to a screw or post implanted directly into the palate of apatient.

FIGS. 25A and 25B illustrate perspective and side views, respectively,of an oral appliance which may have its transducer assembly or acoupling member attached to the gingival surface to conduct vibrationsthrough the gingival tissue and underlying bone.

FIG. 26 illustrates an example of how multiple oral appliance two-waycommunication assemblies or transducers may be placed on multiple teeththroughout the patient's mouth.

FIGS. 27A and 27B illustrate perspective and side views, respectively,of an oral appliance (similar to a variation shown above) which may havea microphone unit positioned adjacent to or upon the gingival surface tophysically separate the microphone from the transducer to attenuate oreliminate feedback.

FIG. 28 illustrates another variation of a removable oral appliancesupported by an arch and having a microphone unit integrated within thearch.

FIG. 29 shows yet another variation illustrating at least one microphoneand optionally additional microphone units positioned around the user'smouth and in wireless communication with the electronics and/ortransducer assembly.

DESCRIPTION

As shown in the embodiment of FIG. 1A, a two way communication system 1includes a mouth wearable communicator 6, one or more body sensors 2,and a linking unit 3 coupled to the mouth wearable communicator and theone or more body sensors, the linking unit adapted to communicate with aremote station. The mouth wearable communicator can include a boneconduction hearing system to transmit sound to the user, and thecommunicator can have an embedded microphone to pick up sound. The mouthwearable communicator can be a custom oral device. One or more medicalsensors can be embedded therein to pick up vital sign information.Alternatively, environmental sensors such as room temperature sensorscan be used to sense parameters from the environment and/or the room,for example. Vital sign can include certain body physiological signalmeasurements while environmental signals may be of interest in firefighting and other similar cases. The environment temperature sensor canbe provided in the linking unit 3 or other devices attached or close tobody. Also there are some other signals beside listed that can be pickedfrom linking unit 3 or even the mouth wearable communicator 6 that maybe of great value. For example “Location (using GPS or cell phonesignals or equivalent method)”, “Speed”, “Acceleration”, “Shock”,“Smoke”, “Light”, “Infra Red”, “Radiation” and “Wind Speed” can helpidentify the location of a Fire Fighter or Miner, and to assess if he orshe is at risk. The mouth wearable communicator can provide a datastorage device such as a solid state memory or a flash storage device.The content of the the data storage device can be encrypted forsecurity. A local transceiver can connect the mouth wearablecommunicator 6 with the one or more body sensors 2 and the linking unit3. The local transceiver can transmit encrypted data for securetransmission if desired. A wireless local area network (LAN) or a wiredLAN can support communications among the mouth wearable communicator 6with the one or more body sensors 2 and the linking unit 3. The LANforms a body link among sensors 2, mouth piece 1 and the linking unit ordevice 3. The linking unit 3 can communicate over a wide area network(WAN) to the remote station 5. The remote station can be a satellite, acellular tower, a relay station mounted on an airplane or a helicopter,or a relay station mounted on a blimp, among others.

A beacon 4 can be positioned on the user's body and communicate with themouth wearable communicator 6 to identify that the user is in need ofassistance. The beacon 4 can provide an audible signal, a locationsignal, a visible signal to request assistance. The beacon 4 can beaffixed to a first responder's uniform and can be activated if theuser's vital signs indicate he/she has been hurt and can help to locatethem in a smoky environment.

The two way communication device can use the body sensor 2 to sense avital sign or a measured parameter such as environment temperature,among others. The vital sign can include body temperature, hydration,heart rate, EKG, EEG, pulse rate, oxygen saturation, respiratory cycle,air flow velocity, potential of hydrogen (pH) level, for example. Themeasured parameter can include environment temperature. The sensor canbe positioned in the linking unit 3 or other devices attached or closeto body. Also other measured parameter signals that can be picked fromthe linking unit 3 or the mouth piece 6 that may be of value, including“Location (using GPS or cell phone signals or equivalent method)”,“Speed”, “Acceleration”, “Shock”, “Smoke”, “Light”, “Infra Red”,“Radiation” and “Wind Speed.” The measure parameters can help identifythe location of a Fire Fighter or Miner, and to assess if he or she isat risk, for example. The body sensor 2 can also include an activitymonitor. For instance accelerometers can monitor whether the subject ismoving, walking or running and relay the information to the remotestation 5.

The two way communication device can have a microphone to pick up sound.The microphone can be an intraoral microphone or an extraoralmicrophone. In one embodiment, the microphone cancels environmentalnoise and transmits a user's voice to the remote station. Thisembodiment provides the ability to cancel environmental noises whiletransmitting subject's own voice to the remote station 5 such as a callcenter. As the microphone is in a fixed location (compared to ordinarywireless communication devices) and very close to user's own voice, thesystem can handle environmental noise reduction that is important inworking in high noise areas. As such, the two way communication devicecan be used by workers in loud environments such as a professionalentertainer or athlete and/or support personnel, a soldier, a medic, afireman, an emergency worker, among others.

The two way communication device can provide a wireless sensor networkthat communicates with the mouth wearable communicator 6, the one ormore body sensors 2, and the linking unit 3. In other embodiments, thelinking unit 3 wirelessly communicates with other linking units of otherusers to form a wireless local area network for detection,identification and communication with a crew.

In one embodiment, the mouth wearable communicator 6 has a housinghaving a shape which is conformable to at least a portion of at leastone tooth; an actuatable transducer disposed within or upon the housingand in vibratory communication with a surface of the at least one tooth;and a wireless communication transceiver coupled to the transducer toprovide received sound to the user and to provide communication for theuser. The two way communication device can be an oral appliance having ashape which conforms to the at least one tooth. An electronic assemblycan be disposed within or upon the housing and which is in communicationwith the transducer.

In another aspect, a method for providing two way communication includesintraorally wearing a mouth wearable communicator; sensing one or morebody parameters or environmental parameters; and linking to the mouthwearable communicator and the one or more body sensors to a remotestation.

Implementations of the above method can include one or more of thefollowing. The system can transmit sound using a bone conduction device.The mouth wearable communicator can be a custom oral device. The systemcan embed one or more sensors in the mouth wearable communicator. Thesystem can store medical or environmental data in the mouth wearablecommunicator. For emergency or military users that may face danger, thesystem can store data in the mouth wearable communicator as a securedblack box device for subsequent forensic analysis.

Turning now to FIGS. 1B-1C, exemplary usage scenarios are shown. Asshown in FIG. 1B, an industrial user is shown using the two waycommunication device. As shown in FIG. 1C, an exemplary two waycommunication device and/or medical monitoring device 1 is shown formilitary applications. In one embodiment, the device 1 provides anelectronic and transducer device that can be attached, adhered, orotherwise embedded into or upon a removable oral appliance or other oraldevice to form a two-way communication assembly. As shown in FIGS.1B-1C, the device can be used by emergency and security personnel,medical personnel, municipal workers, industrial plant workers,individuals in loud environments that require communications (musicians,athletes and their support personnel), and the military, among others.

In another embodiment, the device 1 provides an electronic andtransducer device 4 that can be attached, adhered, or otherwise embeddedinto or upon a removable oral appliance or other oral device to form amedical tag containing patient identifiable information. Such an oralappliance may be a custom-made device fabricated from a thermal formingprocess utilizing a replicate model of a dental structure obtained byconventional dental impression methods. The electronic and transducerassembly may receive incoming sounds either directly or through areceiver to process and amplify the signals and transmit the processedsounds via a vibrating transducer element coupled to a tooth or otherbone structure, such as the maxillary, mandibular, or palatine bonestructure.

The device 1 can include sensors that detect chemicals present in theuser's saliva and provide medical information on the user. The device 1can also sense heart rate, EKG, and other bio-signals that can be pickedup within the mouth. Additionally, the device 1 can communicate with amedical data collection module 2 that can collect vital signs such astemperature, heart rate, EKG, respiration rate, and other vital signs ormedical information. The device 1 can communicate with the module 2through various short range radios such as a Bluetooth radio, forexample.

The device 1 can also communicate through a long range transceiver suchas a short-wave transceiver, a cellular telephone transceiver, or asatellite transceiver 3. Such transceivers can be provided within thedevice 1, or alternatively, can be body worn. In the embodiment of FIG.1, a cellular or satellite transceiver 3 is positioned on a belt worn bythe user. The transceiver 3 communicates with the other devices on theuser's body through the short range radio such as Bluetooth, forexample.

An exemplary process to collect medical information from the user (suchas fire fighting personnel) and for supporting bone-conduction two waycommunication can be as follows:

-   -   Periodically collect vital sign and other medical information    -   Check to see if the user is using the long range transceiver for        talking    -   If long range transceiver is not used for talking, upload        medical history of the user to a remote computer over the long        range transceiver    -   Remote computer detects if the medical data falls outside of an        acceptable range that requires medical intervention    -   Alarm sound is generated to the user alerting him/her that there        is a potential problem and that he/she should contact Command        post    -   If medical intervention is required, the remote computer alerts        the user's commander for action to assist the user    -   Self-help instructions can be sent through the transceiver 3 to        the bone conduction communication device 1

In one embodiment, the medical data would include user identification,triage status, condition, and treatment. The data would be routed via acellular transceiver or a satellite transceiver to a Command Post whereit is processed, stored, relayed to the Internet, and moved back todevices on the field. As a result, data on casualties would beaccessible immediately for operational use by other users, medics,responders, incident commanders and even receiving hospitals that canhelp the user. Real-time information regarding victims and their statusis critical to the overall management of field medical care. Medicalcommand can then coordinate timely information on the number ofcasualties and their needs with the known availability of resources,such as on-scene providers, ambulance locations, and area hospitalcapacities. Real-time information is also provided for determining theappropriate patient destination, depending on the type of injuries andthe capabilities of the receiving facilities.

An exemplary process to collect work information from a plant or siteand for supporting bone-conduction two way communication with the workercan be as follows:

-   -   Periodically collect plant or industrial parameters    -   Check to see if the user is using the long range transceiver for        talking    -   If long range transceiver is not used for talking, upload the        industrial parameters collected by the user to a remote computer        over the long range transceiver    -   Remote computer detects if the collected data falls outside of        an acceptable range that requires intervention    -   If intervention is required, the remote computer alerts the        user's supervisor for action and also activate a beacon mounted        on the user to help identify his/her location in case of smoke        or other issues that could hamper visibility    -   Corrective instructions can be sent through the transceiver to        the bone conduction communication device 1 so that user can fix        problem at the site

In another embodiment for military use, the remote computer can supporta BATTLEFIELD MEDICAL INFORMATION SYSTEMS TACTICAL-JOINT (BMIST-J) forenabling military providers to record, store, retrieve and transfermedical records to the DoD's Clinical Data Repository by synchronizingthe received data. The system supports digital versions of the DD 1380(field medical card) and SF 600 (chronological medical record of care).Diagnostic and treatment decision aids are provided by the system. Thedata captured by the device 1 is also Personal Information Carrier (PIC)compatible. The system provides a secure, legible, electronic records ofbattlefield treatments, contributes to a comprehensive, life-longmedical history, and facilitates medical surveillance. This device canalso help medical personnel to triage soldiers more effectively bynoting vital signs and ranking accordingly.

Turning now to more details on the device 1, as shown in FIG. 1D, apatient's mouth and dentition 10 is illustrated showing one possiblelocation for removably attaching two-way communication assembly 14 uponor against at least one tooth, such as a molar 12. The patient's tongueTG and palate PL are also illustrated for reference. An electronicsand/or transducer assembly 16 may be attached, adhered, or otherwiseembedded into or upon the assembly 14, as described below in furtherdetail.

FIG. 2A shows a perspective view of the patient's lower dentitionillustrating the two-way communication assembly 14 comprising aremovable oral appliance 18 and the electronics and/or transducerassembly 16 positioned along a side surface of the assembly 14. In thisvariation, oral appliance 18 may be fitted upon two molars 12 withintooth engaging channel 20 defined by oral appliance 18 for stabilityupon the patient's teeth, although in other variations, a single molaror tooth may be utilized. Alternatively, more than two molars may beutilized for the oral appliance 18 to be attached upon or over.Moreover, electronics and/or transducer assembly 16 is shown positionedupon a side surface of oral appliance 18 such that the assembly 16 isaligned along a buccal surface of the tooth 12; however, other surfacessuch as the lingual surface of the tooth 12 and other positions may alsobe utilized. The figures are illustrative of variations and are notintended to be limiting; accordingly, other configurations and shapesfor oral appliance 18 are intended to be included herein.

FIG. 2B shows another variation of a removable oral appliance in theform of an appliance 15 which is placed over an entire row of teeth inthe manner of a mouthguard. In this variation, appliance 15 may beconfigured to cover an entire bottom row of teeth or alternatively anentire upper row of teeth. In additional variations, rather thancovering the entire rows of teeth, a majority of the row of teeth may beinstead be covered by appliance 15. Assembly 16 may be positioned alongone or more portions of the oral appliance 15.

FIG. 2C shows yet another variation of an oral appliance 17 having anarched configuration. In this appliance, one or more tooth retainingportions 21, 23, which in this variation may be placed along the upperrow of teeth, may be supported by an arch 19 which may lie adjacent oralong the palate of the user. As shown, electronics and/or transducerassembly 16 may be positioned along one or more portions of the toothretaining portions 21, 23. Moreover, although the variation shownillustrates an arch 19 which may cover only a portion of the palate ofthe user, other variations may be configured to have an arch whichcovers the entire palate of the user.

FIG. 2D illustrates yet another variation of an oral appliance in theform of a mouthguard or retainer 25 which may be inserted and removedeasily from the user's mouth. Such a mouthguard or retainer 25 may beused in sports where conventional mouthguards are worn; however,mouthguard or retainer 25 having assembly 16 integrated therein may beutilized by persons, hearing impaired or otherwise, who may simply holdthe mouthguard or retainer 25 via grooves or channels 26 between theirteeth for receiving instructions remotely and communicating over adistance.

Generally, the volume of electronics and/or transducer assembly 16 maybe minimized so as to be unobtrusive and as comfortable to the user whenplaced in the mouth. Although the size may be varied, a volume ofassembly 16 may be less than 800 cubic millimeters. This volume is, ofcourse, illustrative and not limiting as size and volume of assembly 16and may be varied accordingly between different users.

Moreover, removable oral appliance 18 may be fabricated from variouspolymeric or a combination of polymeric and metallic materials using anynumber of methods, such as computer-aided, machining processes usingcomputer numerical control (CNC) systems or three-dimensional printingprocesses, e.g., stereolithography apparatus (SLA), selective lasersintering (SLS), and/or other similar processes utilizingthree-dimensional geometry of the patient's dentition, which may beobtained via any number of techniques. Such techniques may include useof scanned dentition using intra-oral scanners such as laser, whitelight, ultrasound, mechanical three-dimensional touch scanners, magneticresonance imaging (MRI), computed tomography (CT), other opticalmethods, etc.

In forming the removable oral appliance 18, the appliance 18 may beoptionally formed such that it is molded to fit over the dentition andat least a portion of the adjacent gingival tissue to inhibit the entryof food, fluids, and other debris into the oral appliance 18 and betweenthe transducer assembly and tooth surface. Moreover, the greater surfacearea of the oral appliance 18 may facilitate the placement andconfiguration of the assembly 16 onto the appliance 18.

Additionally, the removable oral appliance 18 may be optionallyfabricated to have a shrinkage factor such that when placed onto thedentition, oral appliance 18 may be configured to securely grab onto thetooth or teeth as the appliance 18 may have a resulting size slightlysmaller than the scanned tooth or teeth upon which the appliance 18 wasformed. The fitting may result in a secure interference fit between theappliance 18 and underlying dentition.

In one variation, with assembly 14 positioned upon the teeth, as shownin FIG. 3, an extra-buccal transmitter assembly 22 located outside thepatient's mouth may be utilized to receive auditory signals forprocessing and transmission via a wireless signal 24 to the electronicsand/or transducer assembly 16 positioned within the patient's mouth,which may then process and transmit the processed auditory signals viavibratory conductance to the underlying tooth and consequently to thepatient's inner ear.

The transmitter assembly 22, as described in further detail below, maycontain a microphone assembly as well as a transmitter assembly and maybe configured in any number of shapes and forms worn by the user, suchas a watch, necklace, lapel, phone, belt-mounted device, etc.

FIG. 4 illustrates a schematic representation of one variation oftwo-way communication assembly 14 utilizing an extra-buccal transmitterassembly 22, which may generally comprise microphone 30 for receivingsounds and which is electrically connected to processor 32 forprocessing the auditory signals. Processor 32 may be connectedelectrically to transmitter 34 for transmitting the processed signals tothe electronics and/or transducer assembly 16 disposed upon or adjacentto the user's teeth. The microphone 30 and processor 32 may beconfigured to detect and process auditory signals in any practicablerange, but may be configured in one variation to detect auditory signalsranging from, e.g., 250 Hertz to 20,000 Hertz.

With respect to microphone 30, a variety of various microphone systemsmay be utilized. For instance, microphone 30 may be a digital, analog,and/or directional type microphone. Such various types of microphonesmay be interchangeably configured to be utilized with the assembly, ifso desired.

Power supply 36 may be connected to each of the components intransmitter assembly 22 to provide power thereto. The transmittersignals 24 may be in any wireless form utilizing, e.g., radio frequency,ultrasound, microwave, Blue Tooth® (BLUETOOTH SIG, INC., Bellevue,Wash.), etc. for transmission to assembly 16. Assembly 22 may alsooptionally include one or more input controls 28 that a user maymanipulate to adjust various acoustic parameters of the electronicsand/or transducer assembly 16, such as acoustic focusing, volumecontrol, filtration, muting, frequency optimization, sound adjustments,and tone adjustments, etc.

The signals transmitted 24 by transmitter 34 may be received byelectronics and/or transducer assembly 16 via receiver 38, which may beconnected to an internal processor for additional processing of thereceived signals. The received signals may be communicated to transducer40, which may vibrate correspondingly against a surface of the tooth toconduct the vibratory signals through the tooth and bone andsubsequently to the middle ear to facilitate hearing of the user.Transducer 40 may be configured as any number of different vibratorymechanisms. For instance, in one variation, transducer 40 may be anelectromagnetically actuated transducer. In other variations, transducer40 may be in the form of a piezoelectric crystal having a range ofvibratory frequencies, e.g., between 250 to 4000 Hz.

Power supply 42 may also be included with assembly 16 to provide powerto the receiver, transducer, and/or processor, if also included.Although power supply 42 may be a simple battery, replaceable orpermanent, other variations may include a power supply 42 which ischarged by inductance via an external charger. Additionally, powersupply 42 may alternatively be charged via direct, coupling to analternating current (AC) or direct current (DC) source. Other variationsmay include a power supply 42 which is charged via a mechanicalmechanism, such as an internal pendulum or slidable electricalinductance charger as known in the art, which is actuated via, e.g.,motions of the jaw and/or movement for translating the mechanical motioninto stored electrical energy for charging power supply 42.

In another variation of assembly 16, rather than utilizing anextra-buccal transmitter, two-way communication assembly 50 may beconfigured as an independent assembly contained entirely within theuser's mouth, as shown in FIG. 5. Accordingly, assembly 50 may includean internal microphone 52 in communication with an on-board processor54. Internal microphone 52 may comprise any number of different types ofmicrophones, as described above. Processor 54 may be used to process anyreceived auditory signals for filtering and/or amplifying the signalsand transmitting them to transducer 56, which is in vibratory contactagainst the tooth surface. Power supply 58, as described above, may alsobe included within assembly 50 for providing power to each of thecomponents of assembly 50 as necessary.

In order to transmit the vibrations corresponding to the receivedauditory signals efficiently and with minimal loss to the tooth orteeth, secure mechanical contact between the transducer and the tooth isideally maintained to ensure efficient vibratory communication.Accordingly, any number of mechanisms may be utilized to maintain thisvibratory communication.

In one variation as shown in FIG. 6A, a partial cross-sectional view ofa removable oral appliance 60 is shown placed over or upon a tooth TH.Electronics and/or transducer housing 62 may be seen defined along oralappliance 60 such that housing 62 is aligned or positioned adjacent to aside surface, buccal and/or lingual surface, of the tooth TH. Housing 62may provide protection to the electronics and/or transducer assemblyfrom the environment of the mouth.

An electronics and/or transducer assembly 64 may be simply placed,embedded, or encapsulated within housing 62 for contacting the toothsurface. In this variation, assembly 64 may be adhered against the toothsurface via an adhesive surface or film 66 such that contact ismaintained between the two. As shown in FIG. 6B, a removable backing 68may be adhered onto adhesive surface 66 and removed prior to placementupon the tooth surface. In this manner, assembly 64 may be replaced uponthe tooth as necessary with additional electronics and/or transducerassemblies.

Aside from an adhesive film 66, another alternative may utilize anexpandable or swellable member to ensure a secure mechanical contact ofthe transducer against the tooth. As shown in FIG. 7, an osmotic patchor expandable hydrogel 74 may be placed between housing 62 andelectronics and/or transducer assembly 72. After placement of oralappliance 60, hydrogel 74 may absorb some fluids, either from anysurrounding fluid or from a fluid introduced into hydrogel 74, such thathydrogel 74 expands in size to force assembly 72 into contact againstthe tooth surface. Assembly 72 may be configured to define a contactsurface 70 having a relatively smaller contact area to facilitateuniform contact of the surface 70 against the tooth. Such a contactsurface 70 may be included in any of the variations described herein.Additionally, a thin encapsulating layer or surface 76 may be placedover housing 62 between contact surface 70 and the underlying tooth toprevent any debris or additional fluids from entering housing 62.

Another variation is shown in FIG. 8, which shows electronics and/ortransducer assembly 80 contained within housing 62. In this variation,one or more biasing elements 82, e.g., springs, pre-formed shape memoryelements, etc., may be placed between assembly 80 and housing 62 toprovide a pressing force on assembly 80 to urge the device against theunderlying tooth surface, thereby ensuring mechanical contact.

In yet another variation, the electronics may be contained as a separateassembly 90 which is encapsulated within housing 62 and the transducer92 may be maintained separately from assembly 90 but also within housing62. As shown in FIG. 9, transducer 92 may be urged against the toothsurface via a spring or other biasing element 94 and actuated via any ofthe mechanisms described above.

In other variations as shown in FIG. 10, electronics and/or transducerassembly 100 may be configured to have a ramped surface 102 inapposition to the tooth surface. The surface 102 may be angled away fromthe occlusal surface of the tooth. The assembly 100 may be urged via abiasing element or spring 106 which forces the ramped surface 102 topivot about a location 104 into contact against the tooth to ensurecontact for the transducer against the tooth surface.

FIG. 11 illustrates another similar variation in electronics and/ortransducer assembly 110 also having a ramped surface 112 in appositionto the tooth surface. In this variation, the ramped surface 112 may beangled towards the occlusal surface of the tooth. Likewise, assembly 110may be urged via a biasing element or spring 116 which urges theassembly 110 to pivot about its lower end such that the assembly 110contacts the tooth surface at a region 114.

In yet another variation shown in FIG. 12, electronics and/or transducerassembly 120 may be positioned within housing 62 with an interface layer122 positioned between the assembly 120 and the tooth surface. Interfacelayer 122 may be configured to conform against the tooth surface andagainst assembly 120 such that vibrations may be transmitted throughlayer 122 and to the tooth in a uniform manner. Accordingly, interfacelayer 122 may be made from a material which attenuates vibrationsminimally. Interface layer 122 may be made in a variety of forms, suchas a simple insert, an O-ring configuration, etc. or even in a gel orpaste form, such as denture or oral paste, etc. Additionally, layer 122may be fabricated from various materials, e.g., hard plastics orpolymeric materials, metals, etc.

FIG. 13 illustrates yet another variation in which electronics and/ortransducer assembly 130 may be urged against the tooth surface via amechanical mechanism. As shown, assembly 130 may be attached to astructural member 132, e.g., a threaded member or a simple shaft, whichis connected through housing 62 to an engagement member 134 locatedoutside housing 62. The user may rotate engagement member 134 (asindicated by rotational arrow 136) or simply push upon member 134 (asindicated by linear arrow 138) to urge assembly 130 into contact againstthe tooth. Moreover, actuation of engagement member 134 may beaccomplished manually within the mouth or through the user's cheek oreven through manipulation via the user's tongue against engagementmember 134.

Another variation for a mechanical mechanism is illustrated in FIG. 14.In this variation, electronics and/or transducer assembly 140 may definea portion as an engaging surface 142 for contacting against a cam orlever mechanism 144. Cam or lever mechanism 144 may be configured topivot 146 such that actuation of a lever 148 extending through housing62 may urge cam or lever mechanism 144 to push against engaging surface142 such that assembly 140 is pressed against the underlying toothsurface.

In yet another variation, the electronics 150 and the transducer 152 maybe separated from one another such that electronics 150 remain disposedwithin housing 62 but transducer 152, connected via wire 154, is locatedbeneath dental oral appliance 60 along an occlusal surface of the tooth,as shown in FIG. 15. In such a configuration, vibrations are transmittedvia the transducer 152 through the occlusal surface of the tooth.Additionally, the user may bite down upon the oral appliance 60 andtransducer 152 to mechanically compress the transducer 152 against theocclusal surface to further enhance the mechanical contact between thetransducer 152 and underlying tooth to further facilitate transmissiontherethrough.

In the variation of FIG. 16, another example for a bite-enhancedcoupling mechanism is illustrated where electronics and/or transducerassembly 160 defines an angled interface surface 162 in apposition to acorrespondingly angled engaging member 164. A proximal end of engagingmember 164 may extend through housing 62 and terminate in a pushermember 166 positioned over an occlusal surface of the tooth TH. Onceoral appliance 68 is initially placed over tooth TH, the user may bitedown or otherwise press down upon the top portion of oral appliance 60,thereby pressing down upon pusher member 166 which in turn pushes downupon engaging member 164, as indicated by the arrow. As engaging member164 is urged downwardly towards the gums, its angled surface may pushupon the corresponding and oppositely angled surface 162 to urgeassembly 160 against the tooth surface and into a secure mechanicalcontact.

In yet another variation, an electronics and/or transducer assembly 170may define a channel or groove 172 along a surface for engaging acorresponding dental anchor 174, as shown in FIG. 17. Dental anchor 174may comprise a light-curable acrylate-based composite material adhereddirectly to the tooth surface. Moreover dental anchor 174 may beconfigured in a shape which corresponds to a shape of channel or groove172 such that the two may be interfitted in a mating engagement. In thismanner, the transducer in assembly 170 may vibrate directly againstdental anchor 174 which may then transmit these signals directly intothe tooth TH.

FIGS. 18A and 18B show partial cross-sectional side and top views,respectively, of another variation in which oral appliance 180 maydefine a number of channels or grooves 184 along a top portion of oralappliance 180. Within these channels or grooves 184, one or moretransducers 182, 186, 188, 190 may be disposed such that they are incontact with the occlusal surface of the tooth and each of thesetransducers may be tuned to transmit frequencies uniformly.Alternatively, each of these transducers may be tuned to transmit onlyat specified frequency ranges. Accordingly, each transducer can beprogrammed or preset for a different frequency response such that eachtransducer may be optimized for a different frequency response and/ortransmission to deliver a relatively high-fidelity sound to the user.

In yet another variation, FIGS. 19A and 19B illustrate an oral appliance200 which may be pre-formed from a shape memory polymer or alloy or asuperelastic material such as a Nickel-Titanium alloy, e.g., Nitinol.FIG. 19A shows oral appliance 200 in a first configuration where members202, 204 are in an unbiased memory configuration. When placed upon oragainst the tooth TH, members 202, 204 may be deflected into a secondconfiguration where members 202′, 204′ are deformed to engage tooth THin a secure interference fit, as shown in FIG. 19B. The biased member204′ may be utilized to press the electronics and/or transducer assemblycontained therein against the tooth surface as well as to maintainsecurement of the oral appliance 200 upon the tooth TH.

Similarly, as shown in FIG. 20, removable oral appliance 210 may havebiased members to secure engage the tooth TH, as above. In thisvariation, the ends of the members 212, 214 may be configured intocurved portions under which a transducer element 218 coupled toelectronics assembly 216 may be wedged or otherwise secured to ensuremechanical contact against the tooth surface.

FIG. 21 shows yet another variation in which the oral appliance isomitted entirely. Here, a composite dental anchor or bracket 226, asdescribed above, may be adhered directly onto the tooth surface.Alternatively, bracket 226 may be comprised of a biocompatible materiale.g., stainless steel, Nickel-Titanium, Nickel, ceramics, composites,etc., formed into a bracket and anchored onto the tooth surface. Thebracket 226 may be configured to have a shape 228 over which anelectronics and/or transducer assembly 220 may be slid over or upon viaa channel 222 having a corresponding receiving configuration 224 forengagement with bracket 226. In this manner, assembly 220 may bedirectly engaged against bracket 226, through which a transducer maydirectly vibrate into the underlying tooth TH. Additionally, in theevent that assembly 220 is removed from the tooth TH, assembly 220 maybe simply slid or rotated off bracket 226 and a replacement assembly maybe put in its place upon bracket 226.

FIGS. 22A and 22B show partial cross-sectional side and perspectiveviews, respectively, of yet another variation of an oral appliance 230.In this variation, the oral appliance 230 may be configured to omit anocclusal surface portion of the oral appliance 230 and instead engagesthe side surfaces of the tooth TH, such as the lingual and buccalsurfaces only. The electronics and/or transducer assembly 234 may becontained, as above, within a housing 232 for contact against the toothsurface. Additionally, as shown in FIG. 22B, one or more optionalcross-members 236 may connect the side portions of the oral appliance230 to provide some structural stability when placed upon the tooth.This variation may define an occlusal surface opening 238 such that whenplaced upon the tooth, the user may freely bite down directly upon thenatural occlusal surface of the tooth unobstructed by the oral appliancedevice, thereby providing for enhanced comfort to the user.

In yet other variations, vibrations may be transmitted directly into theunderlying bone or tissue structures rather than transmitting directlythrough the tooth or teeth of the user. As shown in FIG. 23A, an oralappliance 240 is illustrated positioned upon the user's tooth, in thisexample upon a molar located along the upper row of teeth. Theelectronics and/or transducer assembly 242 is shown as being locatedalong the buccal surface of the tooth. Rather than utilizing atransducer in contact with the tooth surface, a conduction transmissionmember 244, such as a rigid or solid metallic member, may be coupled tothe transducer in assembly 242 and extend from oral appliance 240 to apost or screw 246 which is implanted directly into the underlying bone248, such as the maxillary bone, as shown in the partial cross-sectionalview of FIG. 23B. As the distal end of transmission member 244 iscoupled directly to post or screw 246, the vibrations generated by thetransducer may be transmitted through transmission member 244 anddirectly into post or screw 246, which in turn transmits the vibrationsdirectly into and through the bone 248 for transmission to the user'sinner ear.

FIG. 24 illustrates a partial cross-sectional view of an oral appliance250 placed upon the user's tooth TH with the electronics and/ortransducer assembly 252 located along the lingual surface of the tooth.Similarly, the vibrations may be transmitted through the conductiontransmission member 244 and directly into post or screw 246, which inthis example is implanted into the palatine bone PL. Other variationsmay utilize this arrangement located along the lower row of teeth fortransmission to a post or screw 246 drilled into the mandibular bone.

In yet another variation, rather utilizing a post or screw drilled intothe underlying bone itself, a transducer may be attached, coupled, orotherwise adhered directly to the gingival tissue surface adjacent tothe teeth. As shown in FIGS. 25A and 25B, an oral appliance 260 may havean electronics assembly 262 positioned along its side with an electricalwire 264 extending therefrom to a transducer assembly 266 attached tothe gingival tissue surface 268 next to the tooth TH. Transducerassembly 266 may be attached to the tissue surface 268 via an adhesive,structural support arm extending from oral appliance 260, a dental screwor post, or any other structural mechanism. In use, the transducer mayvibrate and transmit directly into the underlying gingival tissue, whichmay conduct the signals to the underlying bone.

For any of the variations described above, they may be utilized as asingle device or in combination with any other variation herein, aspracticable, to achieve the desired hearing level in the user. Moreover,more than one oral appliance device and electronics and/or transducerassemblies may be utilized at any one time. For example, FIG. 26illustrates one example where multiple transducer assemblies 270, 272,274, 276 may be placed on multiple teeth. Although shown on the lowerrow of teeth, multiple assemblies may alternatively be positioned andlocated along the upper row of teeth or both rows as well. Moreover,each of the assemblies may be configured to transmit vibrations within auniform frequency range. Alternatively in other variations, differentassemblies may be configured to vibrate within non-overlapping frequencyranges between each assembly. As mentioned above, each transducer 270,272, 274, 276 can be programmed or preset for a different frequencyresponse such that each transducer may be optimized for a differentfrequency response and/or transmission to deliver a relativelyhigh-fidelity sound to the user.

Moreover, each of the different transducers 270, 272, 274, 276 can alsobe programmed to vibrate in a manner which indicates the directionalityof sound received by the microphone worn by the user. For example,different transducers positioned at different locations within theuser's mouth can vibrate in a specified manner by providing sound orvibrational queues to inform the user which direction a sound wasdetected relative to an orientation of the user. For instance, a firsttransducer located, e.g., on a user's left tooth, can be programmed tovibrate for sound detected originating from the user's left side.Similarly, a second transducer located, e.g., on a user's right tooth,can be programmed to vibrate for sound detected originating from theuser's right side. Other variations and queues may be utilized as theseexamples are intended to be illustrative of potential variations.

In variations where the one or more microphones are positioned. Inintra-buccal locations, the microphone may be integrated directly intothe electronics and/or transducer assembly, as described above. However,in additional variation, the microphone unit may be positioned at adistance from the transducer assemblies to minimize feedback. In oneexample, similar to a variation shown above, microphone unit 282 may beseparated from electronics and/or transducer assembly 280, as shown inFIGS. 27A and 27B. In such a variation, the microphone unit 282positioned upon or adjacent to the gingival surface 268 may beelectrically connected via wire(s) 264.

Although the variation illustrates the microphone unit 282 placedadjacent to the gingival tissue 268, unit 282 may be positioned uponanother tooth or another location within the mouth. For instance, FIG.28 illustrates another variation 290 which utilizes an arch 19connecting one or more tooth retaining portions 21, 23, as describedabove. However, in this variation, the microphone unit 294 may beintegrated within or upon the arch 19 separated from the transducerassembly 292. One or more wires 296 routed through arch 19 mayelectrically connect the microphone unit 294 to the assembly 292.Alternatively, rather than utilizing a wire 296, microphone unit 294 andassembly 292 may be wirelessly coupled to one another, as describedabove.

In yet another variation for separating the microphone from thetransducer assembly, FIG. 29 illustrates another variation where atleast one microphone 302 (or optionally any number of additionalmicrophones 304, 306) may be positioned within the mouth of the userwhile physically separated from the electronics and/or transducerassembly 300. In this manner, the one or optionally more microphones302, 304, 306 may be wirelessly coupled to the electronics and/ortransducer assembly 300 in a manner which attenuates or eliminatesfeedback, if present, from the transducer.

The applications of the devices and methods discussed above are notlimited to the treatment of hearing loss but may include any number offurther treatment applications. Moreover, such devices and methods maybe applied to other treatment sites within the body. Modification of theabove-described assemblies and methods for carrying out the invention,combinations between different variations as practicable, and variationsof aspects of the invention that are obvious to those of skill in theart are intended to be within the scope of the claims.

What is claimed is:
 1. A device, comprising: a. an actuatable transducerdisposed within or upon a first portion of a housing which is securedand in vibratory communication with a first surface of at least onetooth of a subject, the housing having a second portion which is securedalong a second surface of the at least one tooth opposite to the firstsurface such that an occlusal surface is unobstructed by the first andsecond portions of the housing; b. one or more body sensors positionedwithin or upon the body of the subject; and c. an electronic assemblydisposed within or upon the housing, wherein the one or more bodysensors are in communication with the electronic assembly.
 2. The deviceof claim 1, further comprising a linking unit coupled to the housing andthe one or more body sensors.
 3. The device of claim 2, wherein thelinking unit is adapted to communicate with a remote station.
 4. Thedevice of claim 1, wherein the housing comprises one or more sensorsembedded therein or thereon.
 5. The device of claim 1, wherein thehousing comprises a data storage device.
 6. The device of claim 5,wherein the data storage device is encrypted.
 7. The device of claim 2,further comprising a local transceiver coupling the housing with the oneor more body sensors and the linking unit.
 8. The device of claim 7,wherein the local transceiver transmits encrypted data.
 9. The device ofclaim 2, further comprising a wireless local area network (LAN) or awired LAN coupling the housing with the one or more body sensors and thelinking unit.
 10. The device of claim 2, wherein the linking unit iscoupled to a wide area network (WAN).
 11. The device of claim 3, whereinthe remote station is chosen from: a satellite, a cellular tower, or arelay station.
 12. The device of claim 1, further comprising a beaconcoupled to the housing to identify a person in need of assistance. 13.The device of claim 12, wherein the beacon comprises an audible signal,a location signal, or a visible signal.
 14. The device of claim 1,wherein the one or more body sensors senses a vital sign or-anenvironmental.parameter.
 15. The device of claim 1, wherein the one ormore body sensors senses one or more of: body temperature, environmenttemperature, hydration, heart rate, EKG, EEG, pulse rate, oxygensaturation, respiratory cycle, air flow velocity, and pH level.
 16. Thedevice of claim 1, further comprising a microphone to pick up sound. 17.The device of claim 16, wherein the microphone comprises one or more of:an intraoral microphone, and an extraoral microphone.
 18. The device ofclaim 16, wherein the microphone is configured to transmit a user'svoice.
 19. The device of claim 1, wherein the device is used by one of:workers in loud environments, an entertainer, an athlete, supportpersonnel, a soldier, a medic, a fireman, and an emergency worker. 20.The device of claim 2, comprising a wireless sensor network coupled tothe housing, the one or more body sensors, or the linking unit.
 21. Thedevice of claim 3, wherein the linking unit wirelessly communicates withother linking units to form a network.
 22. The device of claim 21,wherein the network is a local area network or a wide area network. 23.The device of claim 1, wherein the housing further comprises a wirelesscommunication transceiver coupled to the transducer to provide receivedsound to the user and to provide communication for the user.
 24. Thedevice of claim 1, wherein the device comprises an oral appliance havinga shape which conforms to the at least one tooth.
 25. A method forsensing one or more body or environmental parameters, comprising: a.placing a device within the mouth of a subject, the device comprising aan actuatable transducer disposed within or upon a first portion of ahousing such that the actuatable transducer is secured and in vibratorycommunication with a first surface of at least one tooth of the subject,the housing further having a second portion which is secured along asecond surface of the at least one tooth opposite to the first surfacesuch that an occlusal surface is unobstructed by the first and secondportions of the housing; b. sensing one or more body parameters orenvironmental parameters via one or more body sensors positioned withinor upon the body of the subject, where the one or more body sensors arein communication with an electronic assembly disposed within or upon thehousing; and c. linking the device with the one or more body sensors.26. The method of claim 25, wherein the actuatable transducer is apiezoelectric transducer.
 27. The method of claim 25, wherein the deviceis a custom fitted oral device.
 28. The method of claim 25, comprisingembedding one or more sensors in the device.
 29. The method of claim 25,comprising storing medical or environmental data in the device.
 30. Themethod of claim 25, comprising storing data in the device as a securedblack box device for subsequent forensic analysis.
 31. The method ofclaim 25, comprising monitoring user activity.
 32. The method of claim31, wherein at least one of the one or more body sensors is anaccelerometer.
 33. The method of claim 25, wherein linking compriseslinking the device and the one or more body sensors to a remote station.34. The device of claim 1, wherein the housing is custom fitted to oneor more teeth of the subject.
 35. The device of claim 1, wherein thehousing is configured as a mouth wearable communicator.
 36. The deviceof claim 2, wherein the device is configured for two way communicationbetween the device and the linking unit.
 37. The device of claim 1,wherein the actuatable transducer is a piezoelectric transducer.